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  2. International Medical Products Price Guide - Wikipedia

    en.wikipedia.org/wiki/International_Medical...

    The WHO/HAI project selects 50 medicines to survey, including 14 global core medicines, 16 regional core medicines and 20 supplementary medicines. When comparing prices, one dosage form and strength is specified for each medicine. To calculate affordability, a typical treatment schedule for a named indication is specified. For example, [6]: 95

  3. WHO Model List of Essential Medicines - Wikipedia

    en.wikipedia.org/wiki/WHO_Model_List_of...

    The selection and use of essential medicines: report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2019 (including the 21st WHO Model List of Essential Medicines and the 7th WHO Model List of Essential Medicines for Children). Geneva: World Health Organization. 2019. hdl: 10665/330668. ISBN 978-92-4-121030-0.

  4. Standard for the Uniform Scheduling of Medicines and Poisons

    en.wikipedia.org/wiki/Standard_for_the_Uniform...

    Schedule 3 (S3) drugs and poisons, otherwise known as Pharmacist Only Medicines, are substances and preparations for therapeutic use that – are substantially safe in use but require professional advice or counselling by a pharmacist; require pharmacist advice, management, or monitoring; are for ailments or symptoms that –

  5. Medical guideline - Wikipedia

    en.wikipedia.org/wiki/Medical_guideline

    A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of medicine

  6. EudraLex - Wikipedia

    en.wikipedia.org/wiki/EudraLex

    Volume 7 - Guidelines. Volume 8 - Maximum residue limits. Concerning Medicinal Products for Human and Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous: Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

  7. International Council for Harmonisation of Technical ...

    en.wikipedia.org/wiki/International_Council_for...

    In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.

  8. List of stringent regulatory authorities - Wikipedia

    en.wikipedia.org/wiki/List_of_stringent...

    A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...

  9. Good clinical practice - Wikipedia

    en.wikipedia.org/wiki/Good_clinical_practice

    European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]